{
 "site": "https://preventiohub.com",
 "updated": "2026-10-16",
 "currency": "USD",
 "language": "en",
 "note": "Specifications are sourced per device page. Prices are not published: request a quote.",
 "devices": [
  {
   "slug": "acteon-newtron-p5-xs-bled",
   "name": "Acteon Newtron P5 XS B.LED",
   "brand": "Acteon",
   "model": "Newtron P5 XS B.LED",
   "category": "piezo-scaler",
   "type": "Piezo ultrasonic scaler (standalone generator + LED handpiece)",
   "url": "https://preventiohub.com/devices/acteon-newtron-p5-xs-bled/",
   "last_updated": "2026-10-16",
   "manufacturer_url": "https://www.acteongroup.com/en/products/ultrasonics/conservation-ultrasonic-dentistry/newtron-p5xs/newtron-p5-xs-bled/",
   "specs": {
    "Technology": "Piezoelectric ultrasonic generator with SLIM B.LED handpiece",
    "Intended use (manual)": "With an ultrasonic handpiece and dental insert: prophylaxis, periodontics, endodontics, conservative and restorative dentistry",
    "Output frequency": "Minimum 28 kHz; insert vibration frequency ≥ 28 kHz",
    "Insert amplitude": "≤ 200 µm",
    "Power settings": "1 to 20; color ranges: green 1–6 (mainly periodontics), yellow 6–11 (mainly endodontics), blue 11–16 (scaling and conservative dentistry), orange 16–20 (very high power, mainly unsealing/debonding)",
    "Irrigation": "Tank 300 ml or 500 ml (by option); nominal flow at the handpiece tip 5–40 ml/min; purge flow max. 80 ml/min",
    "Operating mode": "Intermittent: 10 minutes ON / 5 minutes OFF",
    "Electrical": "100–240 VAC, 50/60 Hz, 60 VA; handpiece voltage 150 VAC",
    "Size (W × H × D)": "260 × 102 mm (138 mm with the 300 ml tank) × 185 mm",
    "Weight": "1,800 g with pedal, handpiece cord and 300 ml tank",
    "Cords": "The foot-pedal cord and the handpiece cord are not detachable",
    "Handpiece": "Newtron SLIM with a blue or white LED ring depending on configuration",
    "Tips": "\"Over 80 unique tips\"; a color-coding system links each tip ring to one of four power ranges",
    "Other features listed by Acteon": "Irrigation reaches the tip end; quick water disconnect; graduated tank; slim handpiece"
   },
   "regulatory": [
    {
     "region": "United States",
     "text": "FDA 510(k) K132322, \"NEWTRON P5 XS B.LED\", applicant Satelec - Acteon Group, decision date Mar 11, 2014, Substantially Equivalent. Product code ELC (Scaler, Ultrasonic)"
    },
    {
     "region": "Canada",
     "text": "Health Canada medical device licence 93254, \"NEWTRON P5 XS B.LED\", licence holder Satelec, a company of Acteon Group, device class II, first licence date May 8, 2014, status issued (Medical Devices Active Licence Listing, MDALL, checked Oct 16, 2026)"
    }
   ],
   "price": {
    "mode": "on_request",
    "text": "Price on request"
   },
   "unverified": [
    "The manual we read is version V11 (January 2023, French, hosted by a French distributor); Acteon's resources site lists newer revisions (through 2025). Recheck values against the current manual.",
    "Differences between the B.LED and the Bluetooth version: not confirmed.",
    "Tip count and package contents in the US and Canada: confirm with the supplier."
   ],
   "sources": [
    {
     "label": "Acteon: Newtron P5 XS B.LED user manual J62150 V11, NBADFR030K (01/2023), French, copy hosted by a French distributor",
     "url": "https://www.3adentaire.fr/wp-content/uploads/2023/12/NBADFR030K.pdf",
     "type": "Manufacturer manual",
     "accessed": "2026-10-16"
    },
    {
     "label": "Acteon: Newtron P5 XS B.LED product page (page renders client-side; read via search index)",
     "url": "https://www.acteongroup.com/en/products/ultrasonics/conservation-ultrasonic-dentistry/newtron-p5xs/newtron-p5-xs-bled/",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "Acteon My Resources: Newtron P5 XS Bluetooth documentation",
     "url": "https://myresources.acteongroup.com/en/p/newtron-p5-xs-bluetooth.html",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "U.S. FDA 510(k) database (openFDA): K132322",
     "url": "https://api.fda.gov/device/510k.json?search=k_number:K132322",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    },
    {
     "label": "Health Canada MDALL: licence 93254 (NEWTRON P5 XS B.LED)",
     "url": "https://health-products.canada.ca/api/medical-devices/device/?lang=en&type=json&device_name=NEWTRON+P5+XS",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    }
   ],
   "quote_form": {
    "url": "https://preventiohub.com/devices/acteon-newtron-p5-xs-bled/#quote",
    "post": "https://preventiohub.com/request-quote/thanks/",
    "form-name": "quote-request",
    "dispositivo": "acteon-newtron-p5-xs-bled"
   }
  },
  {
   "slug": "acteon-opus",
   "name": "Acteon OPUS",
   "brand": "Acteon",
   "model": "OPUS",
   "category": "combined-system",
   "type": "Combined tabletop system (piezo ultrasonic scaler + air polisher)",
   "url": "https://preventiohub.com/devices/acteon-opus/",
   "last_updated": "2026-10-16",
   "manufacturer_url": "https://www.acteongroup.com/en/products/ultrasonics/conservation-ultrasonic-dentistry/opus/",
   "specs": {
    "System type": "Dual-mode: ultrasonic scaling + air polishing",
    "Ultrasonic technology": "Newtron piezo, \"controlled amplitude\" (Acteon's wording)",
    "Ultrasonic handpiece": "Newtron SLIM B.LED (LED ring)",
    "Ultrasonic power levels": "20 levels in four ranges: Perio 1–9, Endo 6–13, Scaling 10–17, Boost 16–20",
    "Irrigation levels": "30",
    "Tips": "More than 60 (Acteon's documents give different figures; confirm with the supplier)",
    "Air polisher": "SILKY Pen handpiece, 5 power levels (4 for supragingival care, sizes 11–14, and 1 gentle level for periodontal use)",
    "Heated water (air polishing)": "37 °C",
    "Nozzles": "4: Supra (120° spray), Perio Easy, Perio (automatic pressure reduction below 1 bar), Perio Maintenance (0.6 mm powder outlet); chrome-cobalt",
    "Powder system": "\"Grab & Go\" pre-filled bottle, aspirated from the top (\"Top-Aspiration\"), automatic pressurization when the pedal is pressed",
    "Interface": "ColorDrive color coding; handpiece recognition; touchscreen stated to work with wet gloves",
    "Foot control": "Smart pedal with four controls",
    "Dimensions (W × H × D)": "250 × 270 × 320 mm",
    "Weight": "3,700 g",
    "Water tank": "Approx. 800 ml",
    "Water supply": "2–4 bar at inlet, CPC connector",
    "Air supply": "6–7 bar, max. inlet flow 10 L/min, CPC connector",
    "Electrical": "100–240 VAC, 50/60 Hz, max. 100 VA",
    "Cart": "Optional accessory"
   },
   "regulatory": [],
   "price": {
    "mode": "on_request",
    "text": "Price on request"
   },
   "unverified": [
    "Tip count: Acteon's brochure and web page give different figures; shown as \"more than 60\".",
    "Exact starter-kit contents in the US and Canada and any non-SILKY powders approved: confirm with Acteon.",
    "Ultrasonic operating frequency: not published by Acteon for OPUS in the documents we read.",
    "The Acteon product page renders client-side and was read through a search index; re-check it before relying on it.",
    "FDA 510(k): no record found for this model in the openFDA 510(k) database (searched Oct 16, 2026). Ask the supplier for the clearance number or the exemption basis.",
    "Health Canada: no medical device licence found for this model in MDALL (searched Oct 16, 2026). Ask the supplier for the licence number."
   ],
   "sources": [
    {
     "label": "Acteon: brochure \"OPUS – Your Way\" (PDF)",
     "url": "https://assets.ctfassets.net/jj0sqduhxsai/n5lYFACPFi1JVsppPDbP9/1b70bf6ddd1bc4a0c6a2c4c815f28da2/ACTEON_OPUS_YOUR_WAY_A5_V11__2_.pdf",
     "type": "Manufacturer brochure",
     "accessed": "2026-10-16"
    },
    {
     "label": "Acteon: OPUS product page (renders client-side; read via search index)",
     "url": "https://www.acteongroup.com/en/products/ultrasonics/conservation-ultrasonic-dentistry/opus/",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    }
   ],
   "quote_form": {
    "url": "https://preventiohub.com/devices/acteon-opus/#quote",
    "post": "https://preventiohub.com/request-quote/thanks/",
    "form-name": "quote-request",
    "dispositivo": "acteon-opus"
   }
  },
  {
   "slug": "ems-airflow-handy-3-0",
   "name": "EMS AIRFLOW Handy 3.0 / Handy 3.0 PLUS",
   "brand": "EMS",
   "model": "AIRFLOW Handy 3.0 / Handy 3.0 PLUS",
   "category": "air-polisher",
   "type": "Handpiece air polisher (mounts on the dental unit's turbine coupling)",
   "url": "https://preventiohub.com/devices/ems-airflow-handy-3-0/",
   "last_updated": "2026-10-16",
   "manufacturer_url": "https://www.ems-dental.com/en-us/products/airflow-handy-30",
   "specs": {
    "Models offered": "Classic handpiece (supragingival; AIRFLOW COMFORT and SOFT powders) and PLUS handpiece (visible tooth area and pockets up to 4 mm; AIRFLOW PLUS powder)",
    "Connection": "Suited to \"all common turbine connections\", plug and play (EMS page). The manual says it is adaptable to the turbine connection of the dental unit",
    "Water supply at the coupling": "1 to 2.2 bar (1,000–2,200 hPa), service flow 50–80 ml/min",
    "Air supply at the coupling": "Static pressure 2.7 to 3.5 bar (2,700–3,500 hPa)",
    "Weight": "Approx. 0.150 kg",
    "Operating mode": "Continuous operation",
    "Operating conditions": "+10 °C to +40 °C; 30–75% relative humidity; up to 3,000 m",
    "Validated handpiece life": "800 sterilization cycles (manual, 2013 edition: confirm for the current PLUS handpiece)",
    "Refilling": "EASY-FILL system (\"safe, quick and clean refill\")",
    "Ergonomics (EMS wording)": "Swivel head, lightweight body, designed for good visibility of the treatment area",
    "What it does (manual)": "Removes dental plaque, soft deposits and surface stains from pits, grooves, interproximal spaces and smooth tooth surfaces; the powder is confined by a water jet",
    "Origin": "Hand-made in Nyon, Switzerland"
   },
   "regulatory": [
    {
     "region": "United States",
     "text": "FDA 510(k) K132478, \"AIR-FLOW HANDY 3.0\", applicant E.M.S Electro Medical Systems S.A, decision date Apr 11, 2014, Substantially Equivalent. Product code EFB, regulation 872.4200, class 1"
    },
    {
     "region": "United States",
     "text": "FDA 510(k) K151912, \"AIR-FLOW handy 3.0 PLUS\", applicant E.M.S Electro Medical Systems S.A, decision date Feb 3, 2016, Substantially Equivalent. Product code EFB, regulation 872.4200, class 1"
    },
    {
     "region": "Canada",
     "text": "Health Canada medical device licence 104102, \"AIR-FLOW HANDY 3.0 HANDPIECE\", licence holder E.M.S. Electro Medical Systems S.A., device class II, first licence date Jan 6, 2020, status issued (Medical Devices Active Licence Listing, MDALL, checked Oct 16, 2026)"
    }
   ],
   "price": {
    "mode": "on_request",
    "text": "Price on request"
   },
   "unverified": [
    "Heating, adjustable water temperature, nozzle angles and the exact coupling brands included in each package: not stated in the documents we reviewed.",
    "PLUS-handpiece coupling variants: confirm with the supplier.",
    "The manual we read is the 2013 edition (FB-568), which predates the PLUS handpiece naming: confirm PLUS values with EMS."
   ],
   "sources": [
    {
     "label": "EMS: AIRFLOW Handy 3.0 product page",
     "url": "https://www.ems-dental.com/en-us/products/airflow-handy-30",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "EMS: AIRFLOW Handy 3.0 technical data (documents page, FR)",
     "url": "https://www.ems-dental.com/fr-fr/documents/airflow-handy-30",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "EMS: AIR-FLOW handy 3.0 instructions FB-568 (12/2013), copy hosted by KDM",
     "url": "https://www.kdm-online.de/wp-content/uploads/2025/05/air-flow_handy_3.0_bda.pdf",
     "type": "Manufacturer manual",
     "accessed": "2026-10-16"
    },
    {
     "label": "U.S. FDA 510(k) database (openFDA): K132478",
     "url": "https://api.fda.gov/device/510k.json?search=k_number:K132478",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    },
    {
     "label": "U.S. FDA 510(k) database (openFDA): K151912",
     "url": "https://api.fda.gov/device/510k.json?search=k_number:K151912",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    },
    {
     "label": "Health Canada MDALL: licence 104102 (AIR-FLOW HANDY 3.0 HANDPIECE)",
     "url": "https://health-products.canada.ca/api/medical-devices/device/?lang=en&type=json&device_name=HANDY+3.0",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    }
   ],
   "quote_form": {
    "url": "https://preventiohub.com/devices/ems-airflow-handy-3-0/#quote",
    "post": "https://preventiohub.com/request-quote/thanks/",
    "form-name": "quote-request",
    "dispositivo": "ems-airflow-handy-3-0"
   }
  },
  {
   "slug": "ems-airflow-one",
   "name": "EMS AIRFLOW One",
   "brand": "EMS",
   "model": "AIRFLOW One",
   "category": "air-polisher",
   "type": "Tabletop air polisher (air polishing only, no scaler); product code FT-230",
   "url": "https://preventiohub.com/devices/ems-airflow-one/",
   "last_updated": "2026-10-16",
   "manufacturer_url": "https://www.ems-dental.com/products/airflow-one",
   "specs": {
    "Model / code": "AIRFLOW One, FT-230 (EMS's product page lists FT-230/A)",
    "Control unit size (H × W × L)": "245 × 205 × 290 mm",
    "Weight": "Up to 5 kg in full operating condition (instructions for use). EMS's English product page lists a different figure (2.6 kg): confirm with the supplier",
    "Wireless pedal": "Ø 135 × H 35 mm, up to 0.35 kg; Bluetooth 2.4 GHz radio (max 8 dBm EIRP)",
    "Power supply": "100–240 VAC, 50–60 Hz, 4 A max; max. consumption 700 VA; standby 0.5 W max",
    "Operating mode": "Continuous operation; Class I (protective earth required)",
    "Water supply": "2–5 bar, 10–30 °C, salinity max 0.2%, minimum flow 100 ml/min, RECTUS 20KA connector; an EN 1717-compliant inlet is required",
    "Compressed air": "4.5–7 bar, dry, oil-filtered, minimum flow 20 Nl/min at 4.5 bar, RECTUS 21KA connector",
    "Water temperature": "40 °C by default; adjustable settings 0–4; the final spray at the tooth is lukewarm and below 40 °C",
    "Interface": "Interactive touch panel, 10-level interface for power, water temperature and volume",
    "Handpieces": "AIRFLOW MAX (EMS: Laminar AIRFLOW Technology, which EMS says improves visibility and reduces aerosol) and PERIOFLOW MAX (flexible nozzle with a pressure-reducing groove)",
    "Powder chambers": "CLASSIC chamber for CLASSIC powder (supragingival only); PLUS chamber for PLUS powder (supra- and subgingival). The IFU says to use PLUS powder only in the PLUS chamber",
    "Operating conditions": "10–35 °C, 30–75% humidity, up to 2,000 m",
    "Validated life": "Handpiece main bodies: 1,000 sterilization cycles. Expected device service life: 7 years with yearly preventive maintenance",
    "Intended use (IFU)": "Cleaning and polishing teeth by projecting water, air and dental powders: removal of plaque, soft deposits and surface stains; listed uses include surface preparation before bonding or cementation, cleaning for orthodontic patients, implant fixture cleaning before loading, and plaque removal before fluoride or whitening. The IFU also states the device may be used as an air polisher in patients with periodontal disease",
    "Cautions (IFU)": "Not intended for newborns and infants under 2 years. Patients with chronic bronchitis or asthma must not be treated with an air-polishing device. Patients on a low-salt diet must not be treated with sodium-bicarbonate powder. Installation by an EMS-certified person is recommended"
   },
   "regulatory": [
    {
     "region": "United States",
     "text": "FDA 510(k) K190124, \"EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One\", applicant E.M.S. Electro Medical Systems S.A., decision date Oct 20, 2019, Substantially Equivalent. Product code ELC (Scaler, Ultrasonic), regulation 872.4850, class 2"
    },
    {
     "region": "Canada",
     "text": "Health Canada medical device licence 102647, \"AIRFLOW ONE\", licence holder E.M.S. Electro Medical Systems S.A., device class II, first licence date Mar 28, 2019, status issued (Medical Devices Active Licence Listing, MDALL, checked Oct 16, 2026)"
    }
   ],
   "price": {
    "mode": "on_request",
    "text": "Price on request"
   },
   "unverified": [
    "Whether the 5 mm subgingival-pocket indication stated for the AIRFLOW Prophylaxis Master in the same instructions also applies to the AIRFLOW One: confirm with EMS.",
    "Weight: the instructions for use (up to 5 kg, full operating condition) and EMS's English product page differ; confirm with the supplier.",
    "The instructions for use we read is a distributor-hosted copy dated May 2023 (FB-621); a newer revision may exist."
   ],
   "sources": [
    {
     "label": "EMS: AIRFLOW One technical data (documents page, read via search index)",
     "url": "https://www.ems-dental.com/de-de/dokumente/airflow-one",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "EMS: AIRFLOW One product page",
     "url": "https://www.ems-dental.com/products/airflow-one",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "EMS: AIRFLOW One instructions for use FB-621 (copy hosted by Safco Dental, PDF dated May 2023)",
     "url": "https://www.safcodental.com/media/wysiwyg/brochures/AirFlow_One_Instructions.pdf",
     "type": "Manufacturer manual",
     "accessed": "2026-10-16"
    },
    {
     "label": "U.S. FDA 510(k) database (openFDA): K190124",
     "url": "https://api.fda.gov/device/510k.json?search=k_number:K190124",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    },
    {
     "label": "Health Canada MDALL: licence 102647 (AIRFLOW ONE)",
     "url": "https://health-products.canada.ca/api/medical-devices/device/?lang=en&type=json&device_name=AIRFLOW+ONE",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    }
   ],
   "quote_form": {
    "url": "https://preventiohub.com/devices/ems-airflow-one/#quote",
    "post": "https://preventiohub.com/request-quote/thanks/",
    "form-name": "quote-request",
    "dispositivo": "ems-airflow-one"
   }
  },
  {
   "slug": "ems-piezon-no-pain",
   "name": "EMS PIEZON NO PAIN",
   "brand": "EMS",
   "model": "PIEZON NO PAIN",
   "category": "piezo-scaler",
   "type": "Piezo ultrasonic scaling system built into EMS combined units (not sold on its own)",
   "url": "https://preventiohub.com/devices/ems-piezon-no-pain/",
   "last_updated": "2026-10-16",
   "manufacturer_url": "https://www.ems-dental.com/en-us/products/piezon-no-pain1",
   "specs": {
    "Components": "NO PAIN electronic module; original PIEZON handpiece; PS instrument",
    "Principle": "Piezoelectric linear oscillations; EMS's \"intelligent power feedback\" raises or lowers power depending on the resistance detected",
    "Vibration": "EMS FAQ: \"32,000 movements per second\". EMS's manual for the PIEZON Master 700 gives a range of 24–32 kHz, so 32 kHz is the top of the range; the current module's range: confirm with supplier",
    "Water": "Temperature adjustable, \"non-heated up to 40 °C\"",
    "Instruments": "PS (Perio Slim): supra- and subgingival scaling and periodontal debridement up to 10 mm; designed for up to 1,000 treatments, replace when wear reaches 2 mm. PSR/PSL (curved): supra- and subgingival up to 8 mm, adult patients only. P: stubborn calculus, sub- and supragingival up to 4 mm. PI MAX: peri-implant treatment up to 3 mm",
    "EMS training claim": "EMS says \"NO PAIN\" treatment requires all four of: the NO PAIN module integrated into the AIRFLOW Prophylaxis Master, the original PIEZON handpiece, the original PS instrument and a clinician trained by the Swiss Dental Academy. \"Pain-free\" is EMS's wording, not a Preventio Hub claim",
    "Origin": "Made in Nyon, Switzerland",
    "Where it is sold today": "GBT Machine (FT-300A) with PIEZON NO PAIN MAX, PIEZON handpiece LED (EN-060#), three PS instruments (DS-016A), PI starter kit (FS-295#) and handpiece cord (EM-1009); the water bottle supplies both AIRFLOW and PIEZON. Also integrated in the AIRFLOW Prophylaxis Master (EMS footnote)",
    "Max. output": "12 W",
    "Frequency range": "24–32 kHz",
    "Supply": "100–240 VAC, 50–60 Hz, 80 VA",
    "Size (H × W × D) / weight": "225 × 280 × 295 mm; approx. 2.4 kg",
    "Operating mode": "Continuous with irrigation; 10 minutes maximum without irrigation",
    "Electrical classification": "Class I; Type BF applied part; IP20 unit, IPX1 foot pedal",
    "Irrigation": "Left and right bottle selection (two bottles)",
    "Availability of the Master 700": "Not on EMS's current product list (Oct 16, 2026). Two US retailers show it as no longer available: confirm with EMS or a supplier before relying on it"
   },
   "regulatory": [
    {
     "region": "Canada",
     "text": "Health Canada medical device licence 86778, \"PIEZON NO PAIN BUILT IN KIT (licence PIEZON KIT)\", licence holder E.M.S. Electro Medical Systems S.A., device class II, first licence date Jul 29, 2011, status issued (Medical Devices Active Licence Listing, MDALL, checked Oct 16, 2026)"
    }
   ],
   "price": {
    "mode": "on_request",
    "text": "Price on request"
   },
   "unverified": [
    "The current module's frequency range and power: confirm with EMS.",
    "Whether any standalone PIEZON scaler is still sold: confirm with EMS or a supplier.",
    "The Master 700 values are from an EMS manual copy hosted by a German distributor; the current module may differ.",
    "FDA 510(k): no record found for this model in the openFDA 510(k) database (searched Oct 16, 2026). Ask the supplier for the clearance number or the exemption basis."
   ],
   "sources": [
    {
     "label": "EMS: PIEZON NO PAIN product page",
     "url": "https://www.ems-dental.com/en-us/products/piezon-no-pain1",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "EMS: PIEZON Master 700 operation instructions, technical data (copy hosted by a German distributor)",
     "url": "https://www.kdm-online.de/wp-content/uploads/2025/05/ems_piezon_master_700_handbuch.pdf",
     "type": "Manufacturer manual",
     "accessed": "2026-10-16"
    },
    {
     "label": "EMS: GBT Machine product page",
     "url": "https://www.ems-dental.com/en-us/gbt-machine",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "EMS: current product list",
     "url": "https://www.ems-dental.com/en-us/products",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "Benco Dental: PIEZON Master 700 listing (\"No Longer Available\")",
     "url": "https://shop.benco.com/Product/4791-504/piezon-master-700-standard",
     "type": "Retailer listing (availability only)",
     "accessed": "2026-10-16"
    },
    {
     "label": "Sky Dental Supply: PIEZON Master 700 listing (\"Item has been discontinued\")",
     "url": "https://www.skydentalsupply.com/piezon-master-700.htm",
     "type": "Retailer listing (availability only)",
     "accessed": "2026-10-16"
    },
    {
     "label": "Health Canada MDALL: licence 86778 (PIEZON NO PAIN BUILT IN KIT (licence PIEZON KIT))",
     "url": "https://health-products.canada.ca/api/medical-devices/device/?lang=en&type=json&device_name=PIEZON+NO+PAIN",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    }
   ],
   "quote_form": {
    "url": "https://preventiohub.com/devices/ems-piezon-no-pain/#quote",
    "post": "https://preventiohub.com/request-quote/thanks/",
    "form-name": "quote-request",
    "dispositivo": "ems-piezon-no-pain"
   }
  },
  {
   "slug": "hu-friedy-pwr-air",
   "name": "Hu-Friedy PWR Air",
   "brand": "Hu-Friedy",
   "model": "PWR Air",
   "category": "air-polisher",
   "type": "Tabletop air polisher with heated water (air polishing only); article APAIRPOL",
   "url": "https://preventiohub.com/devices/hu-friedy-pwr-air/",
   "last_updated": "2026-10-16",
   "manufacturer_url": "https://www.hufriedygroup.com/en/pwr-pair-pwr-air/pwr-air-air-polishing-device",
   "specs": {
    "Model / article": "PWR Air, APAIRPOL",
    "Power supply": "100–240 V~, 50/60 Hz; max. 90 VA; fuses 5 × 20 mm, T 2AL, 250 V",
    "Water": "Heated by a heating element (temperature steps not stated in the IFU technical data); inlet pressure 1.0–5.0 bar (14.5–72.5 psi), via supplied hose with quick coupling and removable filter",
    "Air": "Inlet pressure 4.5–8.0 bar (65–116 psi), via supplied hose with filter and pressure reducer",
    "Air-polishing functions": "\"Prophy\" and \"Perio\" functions selectable on the touch screen; continuous regulation by knob (IFU); three power modes low / medium / high (brochure)",
    "Weight / size": "4.2 kg; 310 × 260 × 145 mm (L × W × H)",
    "Electrical classification": "Class I; Type B applied part; IP20 (device), IP22 (foot pedal UPFTPEDAL)",
    "Operating conditions": "10–30 °C, 30–75% relative humidity, up to 3,000 m",
    "Handpieces": "90°, 120° and Perio stainless-steel handpieces; PWR Air Perio Subgingival Tips (sterile, disposable, 40 per box)",
    "Pocket depth (Hu-Friedy)": "90° and 120° handpieces: supra- and subgingival use in pockets up to 5 mm; Perio handpiece with disposable tip: optical access in pockets deeper than 5 mm",
    "Powders (Hu-Friedy)": "PWR Classic (sodium bicarbonate) and PWR Perio (glycine), each in mint and neutral; \"hydrophobic effect\" to reduce clogging",
    "Other functions": "One-touch Perio function (reduced air pressure); refill without powering down; automatic internal flush on powder change; energy-saving mode after 20 minutes of inactivity; continuous airflow to help prevent clogging",
    "Patients (IFU)": "Intended for patients over 2 years of age. The IFU lists situations where use is not recommended (upper respiratory tract infections, chronic bronchitis or asthma, pregnancy and breastfeeding, radiotherapy, chemotherapy or antibiotic treatment, acute infectious oral lesions) and powder-specific cautions (low-sodium diet for bicarbonate powders)",
    "Warning (IFU)": "The water spray temperature has a double safety mechanism; patients should still report an excessive increase in temperature"
   },
   "regulatory": [
    {
     "region": "Canada",
     "text": "Health Canada medical device licence 114969, \"PWR AIR UNIT (with PWR AIR and PWR AIR PERIO handpieces)\", licence holder Hu-Friedy Mfg. Co., LLC, device class II, first licence date Feb 25, 2026, status issued (Medical Devices Active Licence Listing, MDALL, checked Oct 16, 2026)"
    }
   ],
   "price": {
    "mode": "on_request",
    "text": "Price on request"
   },
   "unverified": [
    "US availability and FDA status: confirm with Hu-Friedy or the supplier before a request is passed on.",
    "Water temperature steps: not stated in the IFU technical data.",
    "Which handpieces (two or three) are in the package.",
    "The PWR Pair (air polishing plus ultrasonic scaling in one handpiece) is not covered: no official source was reviewed.",
    "The Hu-Friedy product page is largely script-rendered; the specifications come from the IFU and the brochure.",
    "FDA 510(k): no record found for this model in the openFDA 510(k) database (searched Oct 16, 2026). Ask the supplier for the clearance number or the exemption basis."
   ],
   "sources": [
    {
     "label": "Hu-Friedy: PWR Air instructions for use (EN_UMM_PwrAir_00), technical data chapter",
     "url": "https://www.hufriedygroup.com/documents/68584",
     "type": "Manufacturer manual",
     "accessed": "2026-10-16"
    },
    {
     "label": "Hu-Friedy: PWR Air brochure (HFL-1065-NAM-2512, North America edition)",
     "url": "https://www.hufriedygroup.com/documents/68587",
     "type": "Manufacturer brochure",
     "accessed": "2026-10-16"
    },
    {
     "label": "Hu-Friedy: PWR Air product page",
     "url": "https://www.hufriedygroup.com/en/pwr-pair-pwr-air/pwr-air-air-polishing-device",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "Health Canada MDALL: licence 114969 (PWR AIR UNIT (with PWR AIR and PWR AIR PERIO handpieces))",
     "url": "https://health-products.canada.ca/api/medical-devices/device/?lang=en&type=json&device_name=PWR+AIR",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    }
   ],
   "quote_form": {
    "url": "https://preventiohub.com/devices/hu-friedy-pwr-air/#quote",
    "post": "https://preventiohub.com/request-quote/thanks/",
    "form-name": "quote-request",
    "dispositivo": "hu-friedy-pwr-air"
   }
  },
  {
   "slug": "kavo-prophyflex-4",
   "name": "KaVo PROPHYflex 4",
   "brand": "KaVo",
   "model": "PROPHYflex 4",
   "category": "air-polisher",
   "type": "Handpiece air polisher (KaVo MULTIflex or Sirona click'n go coupling)",
   "url": "https://preventiohub.com/devices/kavo-prophyflex-4/",
   "last_updated": "2026-10-16",
   "manufacturer_url": "https://www.kavo.com/en/products/instruments/prophylaxis/prophyflex-4",
   "specs": {
    "Drive air pressure": "3.2–5 bar (46–73 psi)",
    "Air consumption": "10–13 Nl/min",
    "Water pressure": "1.0–2.5 bar (15–36 psi)",
    "Spray water quantity": "Approx. 35–80 cm³ (as printed in the IFU; unit of time not shown)",
    "Spray air pressure": "1.0–2.5 bar (15–36 psi)",
    "Coupling": "\"Fits all MULTIflex (LUX) / MULTIflex LED couplings\" (IFU); KaVo's page adds Sirona click'n go",
    "Powder control": "Three levels by adjusting ring: highest for supragingival work with full cleaning power; middle for sub- and supragingival work with reduced powder; lowest almost powder-free (rinsing and purging, not for stain removal)",
    "Powders (KaVo)": "PROPHYflex Powder (sodium bicarbonate); PROPHYpearls (calcium carbonate); PROPHYflex Perio Powder (glycine, for subgingival treatment, biofilm removal and implant maintenance including titanium polishing). IFU: use only original KaVo powders; do not run RONDOflex powder in the instrument",
    "Cannulas and grip": "Three cannulas available; optional \"power cannula\" for stubborn discoloration; grip sleeve long or short; 360° rotatable grip sleeve",
    "Perio Kit": "Slim perio tip with depth markings and Perio Powder; each perio tip can be reprocessed up to 10 cycles",
    "Intended use (IFU)": "Removal of discoloration and plaque, orthodontics, cleaning before fissure sealing, prosthetics, conservative and aesthetic dentistry",
    "Reprocessing": "Steam sterilizable at 134 °C (−1 / +4 °C); thermal disinfection; powder containers are replaced and reprocessed between patients",
    "Colors / order numbers": "Wave 3.002.8000; Lime 3.002.8200; Flamingo 3.002.8800; S versions 3.004.5900 / 3.004.5930 / 3.004.5950",
    "Safety notes (IFU)": "Patient and operator must wear protective glasses; KaVo recommends working with suction and a mask; the IFU has a section on the risk of air embolism and skin emphysema. Read the IFU before use"
   },
   "regulatory": [
    {
     "region": "United States",
     "text": "FDA 510(k) K181110, \"PROPHYflex 4\", applicant Kaltenbach & Voigt GmbH, decision date Apr 10, 2019, Substantially Equivalent. Product code EFB, regulation 872.4200, class 1"
    },
    {
     "region": "Canada",
     "text": "Health Canada medical device licence 6367, \"PROPHYFLEX 4 (licence KAVO DENTAL HANDPIECES)\", licence holder KaVo Dental GmbH, device class II, first licence date Dec 14, 2018, status issued (Medical Devices Active Licence Listing, MDALL, checked Oct 16, 2026)"
    }
   ],
   "price": {
    "mode": "on_request",
    "text": "Price on request"
   },
   "unverified": [
    "Weight and handpiece dimensions: not stated in the documents reviewed (\"lightweight\" per KaVo).",
    "The IFU we read is the 2018 edition, in German, hosted by a distributor; an up-to-date English IFU was not found.",
    "What the \"S\" versions are, and whether the Sirona coupling needs an adapter: confirm with KaVo or the supplier."
   ],
   "sources": [
    {
     "label": "KaVo: PROPHYflex 4 Gebrauchsanweisung (instructions for use, 2018, German), copy hosted by Henry Schein Austria",
     "url": "https://www.henryschein.at/images/ads/inca_Uploads/1001/47/1001_43843/Gebrauchsanweisung_PROPHYflex_de.pdf",
     "type": "Manufacturer manual",
     "accessed": "2026-10-16"
    },
    {
     "label": "KaVo: PROPHYflex 4 product page",
     "url": "https://www.kavo.com/en/products/instruments/prophylaxis/prophyflex-4",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "U.S. FDA 510(k) database (openFDA): K181110",
     "url": "https://api.fda.gov/device/510k.json?search=k_number:K181110",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    },
    {
     "label": "Health Canada MDALL: licence 6367 (PROPHYFLEX 4 (licence KAVO DENTAL HANDPIECES))",
     "url": "https://health-products.canada.ca/api/medical-devices/device/?lang=en&type=json&device_name=PROPHYFLEX",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    }
   ],
   "quote_form": {
    "url": "https://preventiohub.com/devices/kavo-prophyflex-4/#quote",
    "post": "https://preventiohub.com/request-quote/thanks/",
    "form-name": "quote-request",
    "dispositivo": "kavo-prophyflex-4"
   }
  },
  {
   "slug": "mectron-combi-touch",
   "name": "Mectron Combi Touch",
   "brand": "Mectron",
   "model": "Combi Touch",
   "category": "combined-system",
   "type": "Combined piezoelectric scaler and air polisher (tabletop)",
   "url": "https://preventiohub.com/devices/mectron-combi-touch/",
   "last_updated": "2026-10-16",
   "manufacturer_url": "https://dental.mectron.com/products/airpolishing/units/combi-touch/",
   "specs": {
    "Ultrasonic frequency": "24–36 kHz (Mectron describes the oscillation as around 28,500 Hz)",
    "Ultrasonic modes": "Endo, perio/scaler, restorative and SOFT MODE; power levels 1–5; PULSE MODE for extraction and prosthetics",
    "Ultrasonic irrigation": "Tap-water line (stepless) or removable 500 ml bottle via peristaltic pump: 7 flow levels, about 5 ml/min (level 1) to about 30 ml/min (level 7)",
    "Air polishing": "Selectable \"Prophy\" or \"Perio\" function on the touch screen; two removable powder chambers (prophy and perio) with a refill function; water to the polisher regulated by knob and heated",
    "Polisher pressures": "Prophy function 3.5 bar; perio function 2.7 bar",
    "Supply pressures": "Air input 4–8 bar; water 1–6 bar",
    "Nozzles": "90° and 120° spray heads for supra- and subgingival use in pockets up to 5 mm; Perio nozzle with a disposable sterile Subgingival Perio Tip for deeper pockets",
    "Ultrasonic handpiece": "Slim LED handpiece with circular light, 55 g",
    "Dimensions (l × w × h)": "410 × 260 × 145 mm",
    "Weight": "4.8 kg",
    "Powders": "Mectron sodium-bicarbonate powders (soft M, soft L) and Mectron glycine powder sensitive+. Mectron states that non-original powders void its warranty",
    "Warranty": "2 years; handpiece 1 year"
   },
   "regulatory": [
    {
     "region": "United States",
     "text": "FDA 510(k) K231391, \"Combi Touch\", applicant Mectron S.P.A., decision date May 15, 2023, Substantially Equivalent. Product code ELC (Scaler, Ultrasonic), regulation 872.4850, class 2"
    },
    {
     "region": "Canada",
     "text": "Health Canada medical device licence 98936, \"COMBI TOUCH\", licence holder Mectron S.p.A., device class II, first licence date Apr 6, 2017, status issued (Medical Devices Active Licence Listing, MDALL, checked Oct 16, 2026)"
    }
   ],
   "price": {
    "mode": "on_request",
    "text": "Price on request"
   },
   "unverified": [
    "Electrical rating (voltage/power consumption): not read from a primary Mectron document for this page.",
    "Combi Touch instructions for use: not read for this page.",
    "The catalog dimensions and weight are for the Combi Touch as printed in the Feb 2025 catalog; the manufacturer's current datasheet may differ."
   ],
   "sources": [
    {
     "label": "Mectron: combi touch product page",
     "url": "https://dental.mectron.com/products/airpolishing/units/combi-touch/",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "Mectron: Product catalog (PDF, file created Feb 28, 2025), COMBI touch pages and technical data",
     "url": "https://dental.mectron.com/fileadmin/user_upload/dental/english/pdf/product_brochures/en_bro_product_catalog.pdf",
     "type": "Manufacturer catalog",
     "accessed": "2026-10-16"
    },
    {
     "label": "Mectron: Good Practice in Non-surgical Periodontal Therapy (Nardi), COMBI touch description",
     "url": "https://dental.mectron.com/fileadmin/user_upload/dental/english/pdf/manuals/en_clin_book_nardi.pdf",
     "type": "Manufacturer publication",
     "accessed": "2026-10-16"
    },
    {
     "label": "Mectron: Air-polishing system COMBI touch clinical protocol",
     "url": "https://dental.mectron.com/fileadmin/user_upload/dental/english/pdf/manuals/en_clin_prot_combi_touch.pdf",
     "type": "Manufacturer publication",
     "accessed": "2026-10-16"
    },
    {
     "label": "Mectron: mini catalog 2016/17 (spare-parts list)",
     "url": "https://dental.mectron.com/fileadmin/user_upload/dental/general/pdf/product_brochures/en_bro_minicatalog2016.pdf",
     "type": "Manufacturer catalog",
     "accessed": "2026-10-16"
    },
    {
     "label": "U.S. FDA 510(k) database (openFDA): K231391",
     "url": "https://api.fda.gov/device/510k.json?search=k_number:K231391",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    },
    {
     "label": "Health Canada MDALL: licence 98936 (COMBI TOUCH)",
     "url": "https://health-products.canada.ca/api/medical-devices/device/?lang=en&type=json&device_name=COMBI+TOUCH",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    }
   ],
   "quote_form": {
    "url": "https://preventiohub.com/devices/mectron-combi-touch/#quote",
    "post": "https://preventiohub.com/request-quote/thanks/",
    "form-name": "quote-request",
    "dispositivo": "mectron-combi-touch"
   }
  },
  {
   "slug": "mectron-multipiezo",
   "name": "Mectron multipiezo",
   "brand": "Mectron",
   "model": "multipiezo",
   "category": "piezo-scaler",
   "type": "Piezoelectric ultrasonic scaler (tabletop, touch panel)",
   "url": "https://preventiohub.com/devices/mectron-multipiezo/",
   "last_updated": "2026-10-16",
   "manufacturer_url": "https://dental.mectron.com/en/products/ultrasound/units/multipiezo/",
   "specs": {
    "Operating frequency": "24,000–36,000 Hz; the unit tunes power and frequency automatically for each insert",
    "Functions and power": "3 functions (endo, perio/scaler, restorative), each with seven power levels (0–6); SOFT MODE for sensitive patients; PULSE MODE (restorative level 6) for extractions and prosthetics",
    "Irrigation": "Removable illuminated 500 ml bottle; pump flow 6–28 ml/min across the flow levels (catalog: adjustable in 7 levels)",
    "Dimensions (l × w × h)": "320 × 230 × 145 mm",
    "Weight": "2.4 kg",
    "Electrical": "100–240 V~, 90 VA, 50/60 Hz",
    "Duty cycle": "Intermittent operation: 55 s ON / 30 s OFF with irrigation; 30 s ON / 120 s OFF without irrigation",
    "Handpiece": "LED handpiece with 360° adjustable light; the handpiece can be autoclaved at up to 135 °C for up to 20 minutes",
    "Warranty": "2 years; handpiece 1 year"
   },
   "regulatory": [
    {
     "region": "United States",
     "text": "FDA 510(k) K140965, \"MULTIPIEZO PRO, MULTIPIEZO\", applicant Mectron S.P.A., decision date Aug 20, 2014, Substantially Equivalent. Product code ELC (Scaler, Ultrasonic), regulation 872.4850, class 2"
    },
    {
     "region": "Canada",
     "text": "Health Canada medical device licence 93322, \"MULTIPIEZO\", licence holder Mectron S.p.A., device class II, first licence date May 28, 2014, status issued (Medical Devices Active Licence Listing, MDALL, checked Oct 16, 2026)"
    }
   ],
   "price": {
    "mode": "on_request",
    "text": "Price on request"
   },
   "unverified": [
    "The manual we read is the multipiezo manual dated 2021; the manufacturer's current edition may differ.",
    "Whether the current multipiezo 'touch' set replaces catalog set 05060023 in every country: not confirmed.",
    "Current distributor prices: not published here; price on request."
   ],
   "sources": [
    {
     "label": "Mectron: multipiezo product page",
     "url": "https://dental.mectron.com/en/products/ultrasound/units/multipiezo/",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "Mectron: Product catalog (PDF, file created Feb 28, 2025), multipiezo technical data",
     "url": "https://dental.mectron.com/fileadmin/user_upload/dental/english/pdf/product_brochures/en_bro_product_catalog.pdf",
     "type": "Manufacturer catalog",
     "accessed": "2026-10-16"
    },
    {
     "label": "Mectron: multipiezo use and maintenance manual (© 2021, as hosted by a distributor)",
     "url": "https://www.incotrading.net/descargas/05060023_MANUAL%20USO%20Y%20MANT%20ON%200051%20MULTIPIEZO_05_web-1.pdf",
     "type": "Manufacturer manual",
     "accessed": "2026-10-16"
    },
    {
     "label": "U.S. FDA 510(k) database (openFDA): K140965",
     "url": "https://api.fda.gov/device/510k.json?search=k_number:K140965",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    },
    {
     "label": "Health Canada MDALL: licence 93322 (MULTIPIEZO)",
     "url": "https://health-products.canada.ca/api/medical-devices/device/?lang=en&type=json&device_name=MULTIPIEZO",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    }
   ],
   "quote_form": {
    "url": "https://preventiohub.com/devices/mectron-multipiezo/#quote",
    "post": "https://preventiohub.com/request-quote/thanks/",
    "form-name": "quote-request",
    "dispositivo": "mectron-multipiezo"
   }
  },
  {
   "slug": "nsk-prophy-mate-neo",
   "name": "NSK Prophy-Mate neo",
   "brand": "NSK",
   "model": "Prophy-Mate neo",
   "category": "air-polisher",
   "type": "Coupling-mounted air polishing handpiece with powder case",
   "url": "https://preventiohub.com/devices/nsk-prophy-mate-neo/",
   "last_updated": "2026-10-16",
   "manufacturer_url": "https://www.nsk-dental.com/products/oral-hygiene/oral-prophymate_neo/",
   "specs": {
    "Type": "Air-powered powder-polishing handpiece with powder case (no separate console)",
    "Nozzles": "60° nozzle head fitted; replacement 80° nozzle head supplied. NSK describes 60° for molar and occlusal areas and 80° for anterior teeth",
    "Operating air pressure": "0.27–0.40 MPa (2.7–4.0 kgf/cm²), set at the handpiece hose connection. Higher pressure can crack the powder case",
    "Handling": "360° twist-free swivel joints at the handpiece end and at the powder-case hose end; one-touch connection of handpiece to powder case",
    "Cleaning": "Handpiece can be washed in a thermodisinfector; the powder case and powder-case cap must not be",
    "Sterilization": "Autoclavable up to 135 °C (examples in the manual: 20 min at 121 °C or 15 min at 132 °C). The powder case is autoclaved with its cap removed",
    "Powder": "NSK FLASH pearl (supplied as 5 × 15 g sachets). NSK's manual says to use NSK cleaning powder only and to fill the case with one sachet at a time",
    "Coupling variants listed by NSK": "PMNG-PTL-P (order code Y135029), PMNG-KV-P (Y135030), PMNG-SR-P, PMNG-WH-P, PMNG-BA-P, PMNG-M4-P and PMNG-B2-P. NSK's lineup names Sirona, W&H Roto Quick, Bien-Air Unifix, Midwest 4-hole and Borden 2-hole couplings"
   },
   "regulatory": [
    {
     "region": "United States",
     "text": "FDA 510(k) K112673, \"PROPHY-MATE NEO\", applicant Nakanishi, Inc., decision date Feb 7, 2012, Substantially Equivalent. Product code EFB (Handpiece, Air-Powered, Dental), regulation 872.4200, class 1"
    }
   ],
   "price": {
    "mode": "on_request",
    "text": "Price on request"
   },
   "unverified": [
    "Weight and powder-case capacity of the handpiece set: not published in the NSK documents we checked. (The 2.6 kg and 400 mL figures in NSK's oral-hygiene catalog belong to the Varios Combi Pro unit, not to the Prophy-Mate neo.)",
    "Which coupling each variant code fits is stated by NSK only for PMNG-M4-P and PMNG-B2-P (manual); confirm the code for your unit's coupling with the supplier.",
    "Health Canada: no medical device licence found for this model in MDALL (searched Oct 16, 2026). Ask the supplier for the licence number."
   ],
   "sources": [
    {
     "label": "NSK-Nakanishi International: Prophy-Mate neo product page",
     "url": "https://www.nsk-dental.com/products/oral-hygiene/oral-prophymate_neo/",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "NSK-Nakanishi Spain: Prophy-Mate neo product page (model list)",
     "url": "https://www.spain.nsk-dental.com/products/oral-hygiene/oral-prophymate_neo/",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "NSK: Prophy-Mate neo operation manual (EN, 2015 edition, via NSK Poland)",
     "url": "https://www.nsk.info.pl/uploads/attachements/Prohy-Mate-neo%20Operation%20Manual%20EN.pdf",
     "type": "Manufacturer manual",
     "accessed": "2026-10-16"
    },
    {
     "label": "U.S. FDA 510(k) database (openFDA): K112673",
     "url": "https://api.fda.gov/device/510k.json?search=k_number:K112673",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    }
   ],
   "quote_form": {
    "url": "https://preventiohub.com/devices/nsk-prophy-mate-neo/#quote",
    "post": "https://preventiohub.com/request-quote/thanks/",
    "form-name": "quote-request",
    "dispositivo": "nsk-prophy-mate-neo"
   }
  },
  {
   "slug": "nsk-varios-970",
   "name": "NSK Varios 970 / 970 LUX",
   "brand": "NSK",
   "model": "Varios 970 / 970 LUX",
   "category": "piezo-scaler",
   "type": "Piezo ultrasonic scaler (tabletop control unit + Varios2 handpiece)",
   "url": "https://preventiohub.com/devices/nsk-varios-970/",
   "last_updated": "2026-10-16",
   "manufacturer_url": "https://www.nsk-dental.com/products/oral-hygiene/oral-varios/",
   "specs": {
    "Type": "NE255 (control unit)",
    "Power supply": "AC 120 V or 230 V, 50/60 Hz",
    "Vibration frequency": "28–32 kHz",
    "Maximum output": "11 W (in G mode)",
    "Rated power": "29 VA",
    "Water pressure": "0.1–0.5 MPa",
    "Irrigation": "Two 400 ml bottles; selectable between left bottle, right bottle and tap water",
    "Operating modes": "Perio, Endo and General; the unit remembers power level, water volume and irrigation mode for each mode",
    "Lighting": "Varios 970: no. Varios 970 LUX: yes (LED handpiece, stays lit about 5 seconds after the pedal is released)",
    "Dimensions": "W 160 × D 270 × H 190 mm (including bottles)",
    "Weight": "2.1 kg (excluding attachments)",
    "Operation": "Continuous operation; electrical safety class I, type BF applied part; foot control IPX1",
    "Auto-cleaning": "Flushes tubing, handpiece and tips at the push of a button; the two channels can be flushed independently (about 30 seconds per bottle per the manual)",
    "Sterilization": "Tip, handpiece and tip wrench are autoclavable (maximum 135 °C); control unit, cord and foot control are wiped",
    "Intended use (NSK)": "Scaling, root canal treatment, periodontal and cavity preparation, in dental clinics or offices, by medical professionals such as doctors or dental hygienists"
   },
   "regulatory": [
    {
     "region": "United States",
     "text": "FDA 510(k) K113530, \"Varios 970 / Varios 970 Lux (ultrasonic scaler)\", applicant Nakanishi, Inc., decision date Jan 31, 2013, Substantially Equivalent. Product code ELC, regulation 872.4850, class 2"
    },
    {
     "region": "Canada",
     "text": "Health Canada medical device licence 80864, \"VARIOS 970 ULTRASONIC SCALER\", licence holder Nakanishi Inc., device class II, first licence date Oct 8, 2009, status issued (Medical Devices Active Licence Listing, MDALL, checked Oct 16, 2026)"
    }
   ],
   "price": {
    "mode": "on_request",
    "text": "Price on request"
   },
   "unverified": [
    "Which tips ship in your market (G4/G6/G8 vs G4/G8/G16)."
   ],
   "sources": [
    {
     "label": "NSK: Varios series, Varios 970 section",
     "url": "https://www.nsk-dental.com/products/oral-hygiene/oral-varios/",
     "type": "Manufacturer",
     "accessed": "2026-10-16"
    },
    {
     "label": "NSK: Varios 970 operation manual (EU, type NE255)",
     "url": "https://www.denmark.nsk-dental.com/admin/wp-content/uploads/OM_E0847E000_Varios970_EU.pdf",
     "type": "Manufacturer manual",
     "accessed": "2026-10-16"
    },
    {
     "label": "NSK: Oral Hygiene catalog D1054 (2026)",
     "url": "https://www.nsk-dental.com/admin/wp-content/uploads/Cate_OH_D1054ENv3_260115_LowRes.pdf",
     "type": "Manufacturer catalog",
     "accessed": "2026-10-16"
    },
    {
     "label": "U.S. FDA 510(k) database (openFDA): K113530",
     "url": "https://api.fda.gov/device/510k.json?search=k_number:K113530",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    },
    {
     "label": "Health Canada MDALL: licence 80864 (VARIOS 970 ULTRASONIC SCALER)",
     "url": "https://health-products.canada.ca/api/medical-devices/device/?lang=en&type=json&device_name=VARIOS+970",
     "type": "Regulatory registry",
     "accessed": "2026-10-16"
    }
   ],
   "quote_form": {
    "url": "https://preventiohub.com/devices/nsk-varios-970/#quote",
    "post": "https://preventiohub.com/request-quote/thanks/",
    "form-name": "quote-request",
    "dispositivo": "nsk-varios-970"
   }
  },
  {
   "slug": "woodpecker-pt-e",
   "name": "Woodpecker PT-E",
   "brand": "Woodpecker",
   "model": "PT-E",
   "category": "combined-system",
   "type": "Combined tabletop system (piezo ultrasonic scaler + air polisher)",
   "url": "https://preventiohub.com/devices/woodpecker-pt-e/",
   "last_updated": "2026-10-16",
   "manufacturer_url": "https://www.glwoodpecker.com/",
   "specs": {
    "Product": "PT-E dental scaler and air polisher: integrated system with ultrasonic scaler and air-polishing unit; the mode changes automatically according to the handpiece selected",
    "Ultrasonic vibration frequency": "30 ± 5 kHz, with automatic frequency tracking",
    "Ultrasonic output power": "3 W to 20 W",
    "Maximum tip vibration offset": "90 µm (deviation ± 50%)",
    "Maximum output force (half-excursion)": "10 N (deviation ± 50%)",
    "Tip": "Titanium-alloy tip with elliptical, low-amplitude vibration path",
    "Mains supply": "100–240 V, 50/60 Hz, 3 A–1.5 A; main unit fuse T3.15AH 250 V",
    "Water inlet pressure": "1 to 5 bar (0.1–0.5 MPa)",
    "Compressed-air inlet pressure": "5.5 to 7.5 bar (0.55–0.75 MPa)",
    "Weight (main unit)": "3.1 kg",
    "Size (main unit)": "329 × 267 × 166 mm (L × W × H)",
    "Water bottle": "1,400 ml",
    "Water heating": "Settings OFF / 25 / 30 / 35 / 40 °C for air polishing and OFF / 24 / 28 / 32 / 36 °C for ultrasonic (± 5 °C), nominal values. Woodpecker notes the real temperature depends on the water used and drops along the tubing and with the air spray",
    "Foot-pedal modes": "Normal (tip vibration with water spray / powder-air jet with water); no-water (tip vibration only / air jet only); Power (+3 levels, maximum level 12, returns to the set level on release); Cleaning (water only / air + water)",
    "Ultrasonic modes": "\"G\" (two presets: deep ultrasound and comfortable ultrasound), \"P\" (periodontal treatment and implant maintenance), \"E\" (endodontic treatment and root-canal irrigation)",
    "Tip temperature": "The manual says the tip temperature will not exceed 43 °C when water is supplied; dry operation raises the temperature quickly",
    "Subgingival air polishing": "The manual recommends subgingival air polishing when probing depth exceeds 4 mm; the nozzle is used for pockets of 4–9 mm, no more than 5 seconds per pocket site, with subgingival powder only",
    "Handpieces": "Ultrasonic handpiece with LED; supragingival air-polishing handpiece; detachable, autoclavable handpieces (134 °C, 0.22 MPa)",
    "Powder containers": "Two containers, each with a transparent level scale: one for sodium bicarbonate, one for erythritol or glycine; funnel-shaped container with 360° rotation and built-in illumination",
    "Subgingival nozzle": "Pre-flexible four-hole design: three powder outlets and one water outlet",
    "Medicaments": "In automatic water-supply mode, hydrogen peroxide (3%), sodium hypochlorite (0.2%) and chlorhexidine (5%) can be used",
    "Wireless pedal": "Multifunction wireless pedal, rechargeable lithium battery 3.6 V / 750 mAh; switches off after 10 minutes unused; foot switch IPX1",
    "Electrical classification": "Continuous operation; Class I; tip and nozzle are Type B applied parts; main unit IPX0",
    "Operating environment": "+5 to +40 °C; 30–80% relative humidity; 70–106 kPa; cooling-water temperature +5 to +25 °C",
    "Intended use (ultrasound)": "Scaling (supragingival calculus, stain removal); endo (root-canal preparation, cleaning and irrigation, retrograde preparation, gutta-percha condensation, crown and bridge removal); restorations (cavity preparation, inlay/onlay cementation, amalgam condensation); periodontics (scaling and root planing, periodontal treatment)",
    "Intended use (air polishing)": "Plaque removal; surface preparation before bonding or cementation and before composite restorations; cleaning before orthodontic brackets; cleaning of an implant device before loading; stain removal for shade determination; plaque removal before fluoride and before whitening",
    "Contraindications (manual)": "Haemophilia; respiratory diseases such as asthma and chronic bronchitis; patients and operators with pacemakers or other implanted electronic devices. Powder: low-salt diet; known sensitivity to chlorhexidine or glycine",
    "Target users": "Licensed dentists, adult patients"
   },
   "regulatory": [],
   "price": {
    "mode": "on_request",
    "text": "Price on request"
   },
   "unverified": [
    "The manual we read is a Spanish copy hosted by a distributor; an English edition and an official brochure were not found.",
    "Heating power, air-polishing handpiece names and powder grain sizes are reported only by distributors and are not shown: confirm with Woodpecker or the supplier.",
    "Woodpecker's own site renders client-side and could not be read.",
    "Package contents and powders approved in your market: confirm with the supplier.",
    "FDA 510(k): no record found for this model in the openFDA 510(k) database (searched Oct 16, 2026). Ask the supplier for the clearance number or the exemption basis.",
    "Health Canada: no medical device licence found for this model in MDALL (searched Oct 16, 2026). Ask the supplier for the licence number."
   ],
   "sources": [
    {
     "label": "Guilin Woodpecker: \"PT-E dental scaler and air polisher\" instructions for use, ZMN-SM-962 V1.3 (Aug 29, 2025), Spanish copy hosted by Sanhigia",
     "url": "https://sanhigia.com/media/productattach/m/a/manual_de_instrucciones_-_pte.pdf",
     "type": "Manufacturer manual (Spanish copy)",
     "accessed": "2026-10-16"
    },
    {
     "label": "Woodpecker South Africa (distributor): PT-E \"Main technical specification\" (frequency, power, offset and force match the manual)",
     "url": "https://www.woodpeckerdental.co.za/pt-e",
     "type": "Distributor page",
     "accessed": "2026-10-16"
    }
   ],
   "quote_form": {
    "url": "https://preventiohub.com/devices/woodpecker-pt-e/#quote",
    "post": "https://preventiohub.com/request-quote/thanks/",
    "form-name": "quote-request",
    "dispositivo": "woodpecker-pt-e"
   }
  },
  {
   "slug": "woodpecker-uds-e-led",
   "name": "Woodpecker UDS-E LED",
   "brand": "Woodpecker",
   "model": "UDS-E LED",
   "category": "piezo-scaler",
   "type": "Standalone piezo ultrasonic scaler with LED handpiece and bottle-fed water (scaling, perio, endo)",
   "url": "https://preventiohub.com/devices/woodpecker-uds-e-led/",
   "last_updated": "2026-10-16",
   "manufacturer_url": "https://www.glwoodpecker.com/",
   "specs": {
    "Power supply input": "220–240 V~, 50/60 Hz, 150 mA",
    "Main unit input": "24 V~, 50/60 Hz, 1.3 A",
    "Output primary tip vibration excursion": "≤ 100 µm",
    "Output half-excursion force": "< 2 N",
    "Output tip vibration frequency": "28 kHz ± 3 kHz",
    "Output power": "3 W to 20 W",
    "Fuses": "Main unit T1.6AL 250 V; power supply T0.5AL 250 V",
    "Weight": "Main unit 1.17 kg; external power supply 1 kg",
    "Operating mode": "Continuous operation",
    "Electrical classification": "Class II equipment; Type BF applied part (handpiece and scaling tip); IPX1 for the foot switch",
    "Functions": "Scaling; Perio; Endo; auto-water supply (bottle) or dry mode",
    "Handpiece": "Optical (LED): the lamp lights while the foot switch is pressed and stays on for about 10 seconds after release; detachable, can be autoclaved at 135 °C and 0.22 MPa (LED lamp and light pipe likewise)",
    "Water": "Bottle filled with purified water, mounted inverted on the unit; the WATER button selects auto-water or dry mode. The manual says liquids such as hydrogen peroxide, chlorhexidine and sodium hypochlorite can be used through the auto-water system, followed by purified water for 30 seconds",
    "Tips / wrench": "Scaling tips fitted with a torque wrench; Woodpecker-brand tips required; power must be chosen per tip using the manual's tip power table",
    "Contraindications (manual)": "Haemophilia patients and patients or operators with a heart pacemaker must not use it; heart-disease patients, pregnant women and children: use with caution",
    "Environment": "Operating +5 °C to +40 °C, humidity ≤ 80%; storage −10 °C to +50 °C; not suitable near flammable anaesthetic mixtures",
    "Maker's statement": "The manual describes the device as an ultrasonic scaler \"used for the dental calculus elimination and root canal treatment\""
   },
   "regulatory": [],
   "price": {
    "mode": "on_request",
    "text": "Price on request"
   },
   "unverified": [
    "The manual we read is a 2015 English edition hosted by a Japanese distributor; a current manufacturer edition was not found. Confirm values for units sold today.",
    "Water bottle volume, water-pressure range and control-unit dimensions: not found in the manual.",
    "Some retailers publish a water pressure, package size and a different transformer weight; these are not from the manufacturer's manual and are not used here.",
    "FDA 510(k): no record found for this model in the openFDA 510(k) database (searched Oct 16, 2026). Ask the supplier for the clearance number or the exemption basis.",
    "Health Canada: no medical device licence found for this model in MDALL (searched Oct 16, 2026). Ask the supplier for the licence number."
   ],
   "sources": [
    {
     "label": "Guilin Woodpecker: UDS-E LED ultrasonic scaler user guide (English, 25 pp., PDF created 2015), copy hosted by Kadashika.jp",
     "url": "https://kadashika.jp/images/upload/File/Woodpecker-UDS-E-LED-Ultrasonic-Scaler-Instruction-Manual.pdf",
     "type": "Manufacturer manual (older edition, distributor-hosted copy)",
     "accessed": "2026-10-16"
    }
   ],
   "quote_form": {
    "url": "https://preventiohub.com/devices/woodpecker-uds-e-led/#quote",
    "post": "https://preventiohub.com/request-quote/thanks/",
    "form-name": "quote-request",
    "dispositivo": "woodpecker-uds-e-led"
   }
  }
 ]
}